On March 26, 2021, the Food and Drug Administration (FDA) republished the Over the Counter (OTC) Monograph Drug user fee rates for the fiscal year 2021 under the OTC Monograph Drug User Fee Program (OMUFA). While most OTC facilities will now be required to pay a significant fee to support the FDA’s OTC monograph reform efforts, certain hand sanitizer facilities are exempt. These new fees are due Monday, May 10, 45 days from the date of publication.
In March of 2020, the Coronavirus Aid, Relief, and Economic Security (CARES) Act was passed and established a user fee program that supported the “modernization of how many OTC drugs are regulated by FDA, including changes that would facilitate innovation and make it easier for the FDA to respond to safety issues when they emerge.” Initially, the fees they had planned in December of 2020 were: Monograph Drug Facility (MDF) – $14,060 and Contract Manufacturing Organization (CMO) – $9,373. The newly published Federal Register notice fees have increased to MDF $20,322 and CMO $13,548.
FDA declared that certain hand sanitizer manufacturers, namely those who registered their products during the COVID-19 Public Health Emergency for the first time, will not be required to pay the facility fees. FDA stated they would “not assess facility fees on those companies that first entered the over-the-counter drug market on or after January 27, 2020, solely to produce hand sanitizer products during the COVID-19 Public Health Emergency.” This action is meant to help those that stepped up to the plate to assist with the vast increase in hand sanitizer demand in the initial days and months of the pandemic. This exemption will apply to the newly announced rates. It is important to note that just because this exemption exists, these facilities are not exempt from all other FDA regulatory requirements designated to maintain the American consumer’s health and safety.
If you have registered a facility as an OTC monograph drug facility or CMO, you will need to pay the FDA’s fee by the due date. If you have any questions about the registration and product listings for your facility, contact us today.